ReviewTherapeutic advances in chronic disease2025
Systematic review: the use of tacrolimus in steroid-refractory ulcerative colitis.
Review in Therapeutic advances in chronic disease, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Authors and funding
6 authors.
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Abstract
Background: Steroid-refractory ulcerative colitis (SR-UC) is a severe form of ulcerative colitis (UC) that persists despite high-dose corticosteroid therapy. Management is challenging and often requires biologics, immunosuppressants or colectomy. Tacrolimus, a calcineurin inhibitor with immunomodulatory effects, has emerged as a potential alternative, though its efficacy, safety and long-term outcomes remain uncertain. Objectives: This systematic review evaluates the efficacy and safety of tacrolimus in SR-UC, compares it with anti-tumour necrosis factor (TNF) agents, and examines its role in patients with steroid-refractory ulcerative proctitis (SR-UP). Design: A systematic review was conducted following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were assessed using the Oxford Centre for Evidence-Based Medicine framework. Data sources and methods: A comprehensive search of PubMed and Medline (1998-2025) identified studies reporting clinical remission, response rates, adverse effects and colectomy rates. Subgroup analyses compared oral tacrolimus with anti-TNF therapy and evaluated topical tacrolimus in SR-UP. Results: Seventeen studies (658 patients) met the inclusion criteria. Tacrolimus demonstrated variable efficacy, with clinical remission rates of 9.4%-75.6% and response rates of 28.6%-89.6%. Adverse events, mainly neurotoxicity and nephrotoxicity, occurred in 16.7%-53.0% of cases, sometimes leading to treatment discontinuation. Colectomy rates ranged from 6.1% to 62%. No significant difference was observed between tacrolimus and anti-TNF agents in remission induction, though anti-TNFs had superior long-term outcomes. Topical tacrolimus showed promising efficacy in SR-UP (73.0%-75.0% remission) but was associated with high adverse event rates (45.0%-67.0%). Conclusion: Tacrolimus is a viable option for SR-UC, particularly in combination therapy, but its long-term efficacy remains uncertain. While it is comparable to anti-TNFs for short-term remission, high colectomy rates and adverse effects require careful monitoring. Topical tacrolimus shows promise for SR-UP but requires standardised dosing. Further large-scale trials are needed to optimise treatment strategies and evaluate long-term safety. Trial registration: The review has been registered with PROSPERO (CRD42023432827), the international prospective register of systematic reviews.
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